LEXINGTON, Ky. (August 9, 2016)—Saint Joseph Hospital, part of KentuckyOne Health, announced participation in PARACHUTE IV, a randomized pivotal U.S. trial of the minimally invasive catheter-based Parachute® Ventricular Partitioning Device for the treatment of heart failure.
After a heart attack, many heart failure patients experience enlargement of their left ventricle, causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.
Drs. Nezar Falluji and Michael Schaeffer are leading the trial at Saint Joseph Hospital.
“Saint Joseph Hospital is the first hospital in the Commonwealth to have access to this study,” said Nezar Falluji, MD, cardiology, KentuckyOne Health Cardiology Associates and principle investigator for the trial. “Through the new study, Dr. Schaeffer and I are thrilled to start helping Kentuckians who have suffered from heart failure to hopefully return to the level of activity they desire.”
“There are 20 million patients around the world who suffer with heart failure, and the Parachute device could provide them with new hope,” said, Michael Schaeffer, MD, cardiology, KentuckyOne Health Cardiology Associates. “Many patients who have suffered a heart attack in the United States are also suffering from shortness of breath, fatigue, lack of appetite, increased heart rate and impaired thinking. This device could help improve their lives.”
PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 560 patients with ischemic heart failure at up to 80 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]
About the Parachute® Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.